Herbal

1. Herbal products in Canada
How safe are they?
Anita Kozyrskyj, BSCPHM, MSC
OBJECTIVE To examine existing evidence and inform family physicians about issues concerning
herbal product use in Canada.
QUALITY OF EVIDENCE The Canadian Food and Drug Act and findings of an Expert Advisory
Committee on Herbs and Botanical Preparations were consulted to provide an overview of the
issues regarding herbal product regulation in Canada. Case reports of herbal toxicity were
identified to illustrate some of the hazards of herbal products, and references provided to guide
health professionals in searching the literature for clinical trials that evaluate these drugs' efficacy.
MAIN FINDINGS Herbal products not registered as drugs in Canada are sold as foods and are
exempt from the drug review process that evaluates product efficacy and safety. This places the
public at risk of unwanted effects from the use of herbal products that are adulterated with other
substances and of forgoing effective conventional therapy. Moreover, consumers are exposed to a
plethora of information portraying herbal products as harmless. Some progress has been made to
address these concerns by facilitating the registration ofherbal products as drugs.
CONCLUSIONS Most herbal products that were evaluated were unsafe or ineffective, or no
information was available to evaluate their efficacy. Despite the perception that herbal products
are innocuous, family physicians need to be aware that herbal therapy can be harmful in order to
help their patients make informed choices.
OBJECTIF Examiner les preuves actuelles et informer les medecins de famille de la problematique
entourant l'usage de produits 'a base de plantes au Canada.
QUALITE DES PREUVES On a consulte la Loi canadienne sur les aliments et drogues et les conclu-
sions d'un comite consultatif d'experts sur les herbes et les preparations 'a base de plantes afin de
degager une vue d'ensemble de la problematique entourant les reglements canadiens sur les pro-
duits 'a base de plantes. Des etudes de cas d'intoxication par les plantes ont et6 identifiees afin d'il-
lustrer certains risques relies aux produits 'a base de plantes. On propose aussi des references
pour guider les professionnels de la sante dans leur recherche de documentation sur les essais
cliniques qui evaluent l'utilite de ces produits.
PRINCIPAUX RESULTATS Au Canada, les produits a base de plantes qui ne sont pas inscrits dans
la liste des medicaments sont vendus comme aliments et ne sont donc pas soumis au processus
de revision qui evalue l'utilite et l'innocuite du produit. La population se retrouve donc 'a risque
d'effets secondaires indesirables lorsqu'elle consomme des produits 'a base de plantes auxquels
on a ajoute d'autres substances ou lorsque les patients abandonnent leur traitement conventionnel
pourtant efficace. De plus, les consommateurs sont exposes 'a une plethore de renseignements
qui decrivent les produits 'a base de plantes comme etant inoffensifs. Certains progres ont ete
realises pour apporter une solution 'a ces preoccupations en facilitant l'inscription dans la liste des
medicaments de certains produits 'a base de plantes.
CONCLUSIONS La plupart des produits 'a base de plantes soumis 'a une evaluation etaient soit
dangereux, soit inefficaces ou encore on ne disposait d'aucune information pour en evaluer l'effi-
cacite. Malgre la perception de l'innocuite des produits 'a base de plantes, les medecins de famille
doivent etre conscients que la phytotherapie comporte des dangers ; ils pourront ainsi aider leurs
patients 'a faire des choix eclaires.
Can Fam Physician 1997;43:697-702.
VOL43: APRIL * AVRIL 1997 + Canadian Family Physician Le Medecin defamille canadien 697-*- FOR PRESCRIBING INFORMATION SEE PAGE 7A6

2. CME
Herbal products in Canada
uring the last decade there has been a
resurgence of interest in herbal medicine
in North America.' A recent survey report-
ed that one in five Canadians has used
some form of alternative therapy, such as chiroprac-
tic, herbalism, naturopathy, acupuncture, and home-
opathy.2 These statistics are similar to those obtained
from surveys conducted in the United States and
Australia, where one quarter of respondents indicated
that they had used alternative therapy.3
This "herbal renaissance" has been attributed to a
current trend toward naturalness.1 A survey conduct-
ed in 1977 reported that 42% of consumers surveyed
believed that natural products had no adverse effects
and were more healthful.4 Herbal remedies are pro-
moted as harmless and superior to synthetic drugs
because they are natural.1 A more health-conscious
public is also increasingly aware of the relationship
between nutrition and health.4 These beliefs, coupled
with a general disillusionment with modern medi-
cine's inability to cure everything, have caused North
Americans to turn to alternative medicine.'
Moreover, First Nations and immigrant populations
have largely retained their ethnic medical practices.2
Herbal therapy is not a new phenomenon, and
herbal products are used in many countries of the
world. There are approximately 250 000 species of
flowering plants on this planet, and 25% to 50%/o ofthem
have been used at one time or another for medicinal
purposes. The World Health Organization (WHO)
estimates that 80% of people in developing countries
use traditional medicine, including medicinal plants.5
In Germany herbal preparations are approved, pre-
scribed, and reimbursed as official drugs; they
account for 2% of all prescribed drugs in Germany.6
What should be emphasized at the outset is that
herbal products are not free from side effects,7 that
the manufacture and marketing of herbal products in
Canada is largely unregulated,8 and that mass commu-
nication offers great potential for misinformation and
fraud regarding herbal therapy.4 A survey of patients
attending an AIDS clinic in San Francisco illustrates
some of these points. Twenty-two percent reported
using herbal products during the last 3 months. Of
these patients, 10 were using an Asian herb, six were
unable to identify the herb, and five stated that their
Ms Kozyrskj was a student in the Department of
Community Health Sciences ofthe Faculty ofMedicine at
the University ofManitoba when this article was written.
She is now a Research Associate at the Manitoba Centre
forHealth Policy and Evaluation in Winnipeg.
primary caregivers were unaware that they were tak-
ing these products. Although no side effects were
reported, seven complained of symptoms potentially
exacerbated by the herbal products.9
Patients with chronic conditions or conditions for
which there is no cure are especially susceptible to
trying alternative forms of treatment. In studies of
patients with gynecologic cancer, 21.3% were consum-
ing herbal teas. Another study reported that 25% of
rheumatoid arthritis patients were using herbal
tablets.6 Promotional literature also tends to target
certain populations, such as women, vegetarians, out-
doorsmen, and even drug abusers.1
In view of the fact that Canadians are exposed to
literally thousands of herbal products,2 health profes-
sionals should be aware of the potential for misinfor-
mation and toxicity associated with their use. The
purpose of this paper is to inform family physicians
about issues relating to herbal product use in Canada.
Herbal product regulation in Canada
The Canadian Food and Drug Act prohibits the manu-
facture of food and drugs under unsanitary conditions;
prohibits the sale of food and drugs that are harmful,
adulterated, or manufactured under unsanitary condi-
tions; and prohibits misleading labeling and advertising
of food and drugs.'0 AlM drugs marketed in Canada are
subject to a drug review process, which includes sub-
mission of information on the drug formulation, safety,
and efficacy to the Drugs Directorate of the Health
Protection Branch (HPB)." The Food and Drug Act
defines a drug as "any substance or mixture of sub-
stances manufactured, sold, or represented for use in
1) the diagnosis, treatment, mitigation, or prevention ofa
disease, disorder, abnormal physical state, or the symp-
toms thereof, in man or animal; or 2) restoring, correct-
ing, or modifying organic functions in man or animal.'1
The Food and Drug Act does not distinguish drugs
on the basis of origin, but rather on the basis of the
purpose for which the product is manufactured or
sold.12 Thus, herbal products can be classified as foods
or drugs depending on the purpose for which they are
sold. For example, garlic is a food when it is an ingre-
dient in a spaghetti sauce. Once it is promoted for the
purposes of lowering cholesterol, it is considered a
drug.8 For an herbal product to be sold as a drug, how-
ever, it must be registered with the Drugs Directorate
of the HPB. This includes submission of the identity of
all medicinal and non-medicinal ingredients and their
indications for use, and quantification of ingredient
potency. If an herbal product is not registered with the
HPB, by default, it can be sold as a food.'2
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3. CME
Herbal products in Canada
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Herbal products, as foods, can be sold anywhere,
but have mainly been sold in health food stores and
pharmacies.2 The Food and Drugs Act prohibits adver-
tising or sale offood, drugs, cosmetics, and devices for
the prevention or treatment of non-self-limiting dis-
eases as specified in Schedule A to the Act.10 Many
herbal products are labeled as "dietary aids" or with
nonspecific claims, such as "health-giving properties"
or "for women's health problems." Some products are
labeled for a pharmacologic action, such as "increases
urine flow" or the product name describes its purport-
ed action, eg, "herbal diuretic." Customers are often
referred to information describing the herbal
product's use.1 Health food stores are fined for
promoting the use of an herbal product in the treatment
of disease, but the analogy is that of a speeding ticket
some don't advertise, while others do and are fined, but
continue to advertise (personal communication from
Carmen Kasparek M, Bureau ofNonprescription Drugs,
Drugs Directorate, Health Protection Branch, 1995).
Efficacy and adverse effects
The safety and efficacy of herbal products remains
largely unproven. The revision of the American Food
and Drugs Act in 1962 to prohibit the sale of ineffec-
tive drugs did, however, lead to several efficacy stud-
ies of herbal preparations. Most herbal products
evaluated were found to be unsafe or ineffective, or
no information was available to evaluate their effica-
cy.1 The European pharmaceutical industry is more
active in herbal products research. For example, ran-
domized, controlled studies have been conducted
with valerian, a sleep aid.'3 A newly published text
discusses literature search strategies to identify clini-
cal trials involving herbal products.14
Although effectiveness might be demonstrated in
well-designed clinical trials, lack of standard manufac-
turing conditions leads to the marketing of herbal
products of variable composition. The composition of
raw ingredients is unpredictable due to biologic varia-
tion depending on plant conditions of growth, degree
ofmaturity at the time of collection, and storage.15 The
active ingredients can be further altered, intentionally
and unintentionally, during the extraction process.
For example, the active form of garlic, allicin, which
decreases serum cholesterol, is odoriferous. Steam
distillation to obtain the volatile oil or manufacture of
odourless garlic destroys the active ingredient.4
The efficacy of herbal products has been attrib-
uted to a placebo effect; herbs are commonly used to
treat subjective conditions where a placebo effect is
especially apparent.' While this placebo effect could
be no different from that pursuant to a physician-
prescribed drug,16 the herbal product can cause
unnecessary expenditures and harmful effects from
unknown ingredients.
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4. CME
Herbal products in Canada
Toxicities associated with herb use are not as
uncommon as people think.7 Allergic reactions to
chamomile tea have been reported in individuals with
hay fever allergies. Gastrointestinal effects, such as diar-
rhea, can occur with products containing aloe cathar-
tics. Some of these products are promoted as
weight-loss aids.9 A more serious toxicity is hepatotoxic-
ity arising from pyrrolizidine alkaloids found in herbs
Table 1. Herbal therapy don'ts
Don't collect herbs in the wild unless you are a botanist
Don't buy herbs through mail order
Don't buy herbs at a store unless the source is reliable
Don't buy herbs unless ingredients and quantities are listed
Don't use herbs unless indications for use, directions, and
side effects are known
I..............................................................................................................
Don't use herbs prescribed by a practitioner unless you know
the practitioner's qualifications
Don't use herbs at high doses or for long periods
..............................................................................................................
Don't use herbs for children or during pregnancy or lactation
............I..................................................I...............................................
Don't use herbs in place of prescribed treatment
Datafrom Huxtable7 and McBean Cochran.26
such as comfrey. Infant death has been reported follow-
ing maternal ingestion of teas containing these alka-
loids.7 The herb Ephedra, a vasoconstrictor, can
exacerbate cardiac conditions, such as arrhythmia.17
Some herbs contain anticoagulants and platelet
inhibitors. The ginseng abuse syndrome of insomnia,
confusion, and depression has been reported after long-
term use of ginseng.9 Moreover, the risks of delayed
toxic effects, such as carcinogenicity, are unknown.3
The risks associated with herbal products extend
beyond their natural toxicities. Products could be adul-
terated with spores, pollens, and other active agents
that are toxic and allergenic. A group of rheumatoid
arthritis patients who consumed Chuifong Toukuwan
tablets from Hong Kong noticed symptom improve-
ment within 72 hours, but over the next 12 months
they developed purpuric skin lesions, cushingoid
appearances, hypertension, diabetes, arrhythmias,
compression fractures, and bone marrow suppression.
Samples of Chuifong Toukuwan were found to contain
indomethacin, prednisone, and lead.18 There have also
been common commercial substitutions of herbs. One
such substitution ofginseng with Periploca sepium was
associated with an infant born with hirsutism following
maternal ingestion.19 Moreover, herbal therapy can
also cause adverse effects by omission when patients
forgo conventional treatment for herbal therapy.3
Very little is known about the prevalence or inci-
dence of adverse effects from herbal products. In
Canada, adverse effects due to herbal products are vol-
untarily reported to the Adverse Drug Reaction
Monitoring Division ofthe HPB."7 In addition, it is often
difficult to identify herbal products as the causative
agents. Adverse effects sometimes present as nonspe-
cific symptoms, and the history of herbal product use
is not always apparent Analyzing the contents ofherbal
products can be difficult.7 Even when an adverse drug
reaction stands out as a distinct clinical entity, it can
take years to make the connection to the responsible
agent. The eosinophilia-myalgia syndrome epidemic in
the United States led to hundreds of hospitalizations
and several deaths. Although a few case reports
appeared during 1981 through 1987, the syndrome's
relationship to the amino acid L-tryptophan was not
evident until 1989, after the attack rate had gone up to
more than one victim per 1000 users.6
Changing herbal product regulation
in Canada
Since the late 1970s the WVvHO has passed several reso-
lutions and drafted guidelines for the integration of tra-
ditional remedies into national drug policies and
regulations.20 In Canada, an Expert Advisory
Committee on Herbs and Botanical Preparations to the
HPB was established in 1984 to review the safety and
regulatory control mechanisms for herbal products des-
ignated as foods. Herbal products unacceptable as foods
were added to a "hazardous 1isf' in the Food and Drugs
Act, which lists adulterated substances unacceptable for
sale. The Advisory Committee advocated establishing a
"folldore use" claim, which could include a disclaimer
that the product had not undergone scientific scrutiny.5
Following the Advisory Committee recommenda-
tions, an HPB Information Letter was published in
1987 listing herbal products classified as hazardous.21
Amendments to the hazardous list were published in
the Canada Gazette 1, in 1989 and 1992.22 The second
publication elicited a large response from consumers
and the herbal industry. Thousands of letters and sig-
natures on petitions were received from consumers
concerned about the continued availability of herbal
products. Individuals defended their right to choose
health-enhancing substances according their own
preference or cultural heritage. As a result, the
Expert Advisory Committee on Herbs and Botanical
Preparations was reconvened. In their second report,
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5. CME
HbpdsnnHerbal products in Canada
published in 1993, the committee confirmed their
earlier recommendations and refined the hazardous
list.22 As of 1995, the hazardous list was still
under review.23
In 1990, new Drugs Directorate guidelines for regis-
tering 'Traditional Herbal Medicines" permitted the use
of standard herbal monographs to support efficacy
claims.24 Readers can verify whether a herbal product is
a registered drug in Canada by consulting the Canadian
Drug Identification Codex, which can be accessed
through the Internet from the Health Canada menu
(http://www.hwc.ca/hpb/drugs/htmleng/cdic.html).
Herbal therapy: now what?
Herbal product regulation could well be regarded by
consumers as government efforts to suppress indi-
vidual choice to use natural therapies, but is con-
sumer opposition the symptom of something else?
Why would consumers accept high standards for
drug regulation, but a different standard for herbal
products? Perhaps the answer lies in the philosophy
of alternative medicine. Alternative therapy is said to
emphasize prevention of disease and a holistic
approach to health. Moreover, alternative therapy
practitioners have been reported to involve con-
sumers in decision making.6 Is it surprising, then,
that alternative therapy appeals to consumers who
are disillusioned with current medical care?
Moreover, does alternative therapy not meet current
health care reform goals of health promotion and dis-
ease prevention and individuals' responsibility for
their own health?
Consumer opposition to drug regulation also illus-
trates a blindness to the risks of herbal therapy. While
registration of herbal products as drugs would allow
greater control over manufacturing procedures and
labeling requirements, it will not prevent inappropri-
ate use. It is up to health professionals, as advocates
and protectors of health, to help consumers make
informed choices about using herbal products.25
Health professionals need to become more involved
with the herbal therapy of their individual patients.
Family physicians, pharmacists, and nurses all must
provide accurate information on herbal therapy to
patients and be more vigilant in detecting adverse
effects. As recommended by the WHO, the first step
toward health professional involvement is increased
awareness of the risks of herbal therapy and accep-
tance that consumers will use herbal products.20 Given
the general lack of information on herbal products, it
would be prudent to use common sense when making
recommendations to patients (Table 1726).
For the community, health professional contribu-
tion involves gathering and disseminating informa-
tion on herbal therapy, and participating in the
surveillance of adverse effects of herbal products.
Consumers need to be informed of the risks associ-
ated with herbal products. Education efforts should
target populations most likely to use herbal prod-
ucts, such as AIDS interest groups. Only through the
combination of herbal product regulation and the
involvement of health professionals in herbal therapy
can we implement WHO's 1991 recommendations to
improve "cooperation between those providing tradi-
tional medicine and modern health care, respective-
ly, regarding the use of scientifically proven, safe and
effective traditional remedies to reduce national
drug costs."20 4
Ackmowledgment
I acknowledge the review of the manuscript by Dr Colin
Briggs, Professor, Faculty of Pharmacy, University of
Manitoba.
Correspondence to: Ms Anita Kozyrskyj, Manitoba
Centre for Health Policy and Evaluation, St Boniface
Hospital Research Centre, 2008 - 351 Tache Ave,
Winnipeg, MB R2H2A6
References
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6. PEPCID AC® These changes were rarely of clinical signiticance. No
(famotidine tablets, Frosst Std.) famotidine-treated patients/subjects had to be discontinued
(tamntidine tablets, Frnsst Std.) from therapy because of laboratory adverse experiences.
Tablets 10 mg During marketed use of prescription doses, which are higher
THERAPEUTIC CLASSIFICATION than those recommended for non-prescription use, the
Histamine H, Receptor Antagonist following adverse reactions have been reported: urticaria, liver
enzymes abnormalities, cholestatic jaundice, anaphylaxis,
CLINICAL PHARMACOLOGY angioedema. Toxic epidermal necrolysis has been reported very
PEPCID AC" (famotidine) is a competitive inhibitor of rarely with H-receptor antagonists.
histamine H,-receptors. The primary clinically important The following adverse reactions have been reported; however, a
pharmacologic activity of PEPCID AC" is inhibition of gastric causal relationship to therapy with PEPCID AC® has not been
juice secretion. PEPCID AC' reduces the acid and pepsin established: agitation, confusion, hallucinations, grand mal
content, as well as the volume, of basal, nocturnal, and seizures, rare cases of impotence, thrombocytopenia,
stimulated gastric secretion. pancytopenia, leukopenia and agranulocytosis.
Gynecomastia has been reported rarely. In most cases
INDICATIONS AND CLINICAL USE that were followed up, it was reversible after discontinuing
PEPCID AC® (tamotidine) is indicated in the treatment xl the treatment.
following conditions where a controlled reduction of gastric
secretion is required, such as acid indigestion, heartburn, sour SYMPTOMS AND TREATMENT OF OVERDOSAGE
or upset stomach. PEPCID AC® is also indicated for the There is no experience to date with deliberate overdosage.
prevention of these symptoms when associated with the Doses of up to 800 mg/day have been employed in patients
consumption of food and/or beverage. with pathological hypersecretory conditions with no serious
adverse effects. In the event of overdosage, treatment should be
CONTRAINDICATIONS symptomatic and supportive. Unabsorbed material should be
Hypersensitivity to any component xl this medication, removed from the gastrointestinal tract, the patient should be
monitored, and supportive therapy should be employed.
PRECAUTIONS The oral LD50 of famotidine in male and fernale rats and mice
General was > 5000 mg/kg.
In clinical trials, patients with other underlying acid
gastrointestinal diseases (e.g. duodenal ulcer, gastric ulcer) did DOSAGE AND ADMINISTRATION
not experience complications; in general, they did not exhibit a Adults and children 12 years of age or older: 10 mg, as
clinically significant deterioration in their condition. However, if required to relieve symptoms. For prevention of acid-relat-
patients have difficulty swallowing or if abdominal discomfort ed symptoms associated with the consumption of food
persists, the underlying cause should be determined. and/or beverage: 10 mg one hour before eating. Repeat if
Symptomatic response to therapy with PEPCID AC® symptoms return, up to a maximum of 20 mg in a 24-hour
(famotidine) does not preclude the presence of gastric period.
malignancy. Therapy should not exceed two weeks of continuous
Patients with severe kidney disease, previous history of ulcer treatment without medical consultation.
disease complications, severe coexisting illness, those who are
experiencing unintended weight loss in association with Concomitant use with antacids
dyspeptic symptoms, and those who are middle-aged or older Antacids may be given concomitantly if needed.
with new or recently changed dyspeptic symptoms should
consult a physician before commencing therapy with PHARMACEUTICAL INFORMATION
PEPCID AC®. I. Drug Substance
Patients consuming nonsteroidal anti-inflammatory drugs may Proper name: famotidine
have dyspepsia as a side effect of these medicines and should Cher name:
consult a physician or a pharmacist before taking PEPCID AC®. N'-(aminosulfonya)-3-[[[2-[(diaminomethylene)aminoITherapy should not exceed two weeks of continuous -4-thiazolyl]methyl]thio] Propanimidamide.
treatment without medical consultation.
Structural Formula:
Drug Interactions NSO,NH
Studies with famotidine in man, in animal models, and in vitro H N N CH2-S-CH,-CH, NOH
have shown no significant interference with the disposition of -N NH,compounds metabolized by the hepatic microsomal enzymes, H2N S
e.g., cytochrome P450 system. Compounds tested in man have
included warfarin, theophylline, phenytoin, diazepam, Molecular formula: C8H15N702S3aminopyrine and antipyrine. Indocyanine green as an index of Molecular weight: 337.44
hepatic blood flow and/or hepatic drug extraction has been
tested and no significant effects have been bound. Description: Famotidine is a white to pale yellow crystallineConcomitant use of aluminum hydroxide/magnesium compound that is freely soluble in glacial acetic acid, slightly
hydroxide at commonly used doses, does not influence the soluble in methanol, very slightly soluble in water and
pharmacodynamics or bioavailability of PEPCID AC®. practically insoluble in ethanol.
Famotidine does not affect gastric alcohol dehydrogenase and,
consequently, blood ethanol levels. II. Composition
Use in Obstetrics Film-coated Tablets
Reproductive studies have been performed in rats and Each film-coated tablet for oral administration contains
rabbits at oral doses of up to 2000 and 500 mg/kg/day, 10 mg of famotidine and the following non-medicinal ingredi-
respectively (approximately 2500 and 625 times the maximum ents: hydroxypropyl cellulose, hydroxypropyl methylcellulose,
recommended prescription human dose [80 mg], respectively), magnesium stearate, microcrystalline cellulose, red ferric
and have revealed no evidence of impaired fertility or harm to oxide, starch, talc, titanium dioxide.
the fetus due to famotidine. There are, however, no adequate or
well-controlled studies in pregnant women. Ill. Stability And Storage Recommendation
Since the safe useof PEPCID AC® in pregnant women has not Store at rxom temperalure (15°C - 30°C). Protect fro
been established, pregnant women should not use moisture.
PEPCID AC® unless directed otherwise by a physician. AVAILABILITY OF DOSAGE FORMS
Nursing Mothers No. 3625 -
PEPCID AC® (famotidine) 10 mg film-coated
Famotidine is detectable in human milk. Nursing mothers tablets are rounded-square, pale rose (pink) coloured, with
should either stop this drug or should stop nursing. PEPCID AC embossed on one side. Available in boxes of 12, 6
and 2, individually packaged in PVC/Aluminum blisters.
Pediatric Use Product Monograph available on request to physicians and
Safety and effectiveness in children have not been pamcss
established. PEPCID AC® should not be administered to pharmacists.
children under 12 years of age. Distributed by:
Use in Elderly Patients 9A : MERCK
No dosage adjustment is required based on age. CONSUMER PHARMACEUTICALS
GUELPH, CANADA, NlK 1AS
ADVERSE REACTIONS e Registered Trademark of Merck & Co., Inc.,
PEPCID AC® (famotidine) has been demonstrated to be Merck Frosst Canada, Inc., licensed user
generally welt tolerated. Adverse reactions reported in > 1% 01
patients were headache and dizziness. These occurred with
comparable frequencyin patients treated with placebo.
Laboratory parameters may be affected during treatment with
PEPCID AC®, but the changes are usually not considered seri-
ous. Among the laboratory changes that were reported during
clinical trials were increases in AST, ALT, and WBC count, and
decreases in hemoglobin and hematocrit.
CME
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